ABOUT IQVIA BIOTECH

Flexibility designed for emerging biotech

The world of drug development is rapidly changing, driven by the dramatic evolution of technology and science, and now the impact of a global pandemic. As innovative biotech companies continue to fill the pipeline, IQVIA Biotech is here to help them succeed.

IQVIA Biotech delivers flexible clinical development solutions designed to help biotech and emerging biopharma companies move forward in their effort to get treatments to patients. When you partner with our clinical operations team, you gain expertise from two decades of planning and running clinical trials exclusively for biotech companies. We understand the unique challenges, hurdles, and opportunities you face. From plan development to trial design and execution, we draw on this experience to put together the right solution, and the right team, for you.

For more information, visit our website and follow us on LinkedIn and Twitter.

THOUGHT LEADERSHIP

  • Our regulatory experts are closely following the evolution of regulatory guidance on COVID-19 and the approach taken by global regulatory agencies.

  • This paper examines the requirements for effectively and successfully conducting hematologic oncology clinical trials.

  • How do patients receive necessary continued care when there is limited or no access to providers or trial sites? With the risk of exposure to COVID-19, will immunocompromised patients be safe to participate in trials in the traditional sense now and in the future?

  • This paper explores essential principles for defining the right strategy for natural history studies and how to design such studies in a way that the data can be used as an external comparator to augment future regulatory filings and payer submissions.

  • This paper is the first part of a series of articles aimed at helping the EBP executive and his/her team members better assess the value of a “partnered” outsourcing approach across the continuum of development and commercialization, and potential approaches to mapping out the right fit for their organizational needs.

  • The pandemic has forced the biotech industry to quickly adapt and, as a result, is fueling the modernization of clinical trials. This article will review the biotech perspective of modern clinical trials and explore what the next normal may look like.

  • Increasingly, non-U.S. based companies are looking to bring their innovative investigational products to the U.S. for clinical development. Clearing the U.S. FDA not only ensures access to the largest market but also may provide a smoother path to marketing approval in other countries and markets.

  • While demonstrating the value of a product is important for any organization, the pressure is more acute for small and emerging biotech companies. It’s critical to convey to investors that your drug candidate has the potential to meet the unmet needs of patients today and tomorrow. Explore 3 key components to creating a compelling value story.

  • The global commercial dermatology market is estimated to reach $33.7 billion by 2022. With this momentum and the continued need for safe and effective dermatology treatments, it’s important to understand the strategic needs of clinical trials using novel immuno-dermatology agents.

  • Advancements in science and technology, combined with unmet patient needs, are driving accelerated timelines and creative pathways for oncology drug development.

  • Gene therapies now offer a new trajectory to address the cause of the disease, rather than simply alleviating symptoms. See how gene therapy is changing the trajectory of dermatology therapeutics by direct targeting of mutations.

  • For biotech companies developing an immuno-oncology (IO) therapy, the complexity of oncology clinical trials takes on new dimensions. Review the current IO landscape and considerations for biotech companies preparing for IO studies.

     
  • Nearly 60 percent of clinical trials have protocol amendments, leading to significant timeline delays and additional cost. Discover how four data-driven protocol design analyses can increase the chances of study success in dermatology clinical trials.

  • The future is promising for the field of cell therapy. However, there are still challenges to overcome, including the length of time required to manufacture cell therapies, high costs, and logistical challenges.

  • Dermatology patients are eager to participate in trials from their homes during the COVID-19 pandemic. Sponsors and investigators managing dermatology clinical trials have quickly embraced remote and virtual tools to keep patients safe and keep trials moving forward. Join our webinar and learn how to incorporate virtual approaches into the design and delivery of dermatology trials – to lower overall study risks and increase patient engagement.

  • While it is not practical to think every dermatology trial can be 100% virtual, it is possible to customize and incorporate virtual aspects into these programs with a hybrid approach.

  • IQVIA™ Biotech analyzed the approaches of companies that launched products for the first time to understand their funding/commercialization strategies. This white paper presents the results of this analysis and discuss the implications for the three types of players involved.

  • Patients living with cancer are among the most vulnerable during the pandemic, but sponsors and researchers understand oncology drug development must continue. This paper discusses how COVID-19 is driving change in the oncology trial landscape and how these insights may shape the future of post-pandemic clinical development.

CONTACT INFORMATION

IQVIA Biotech

2400 Ellis Road

Durham, NC 27703

UNITED STATES

Phone: +1-910-200-1845

Contact: Daniel Halligan

FEATURED ARTICLES

  • IQVIA Biotech was approached by a clinical-stage biopharmaceutical company to run its Phase II prostate cancer drug trial in the U.S. For more information, download the available case study.

  • IQVIA Biotech was selected to help a U.S. biopharmaceutical company examine the safety and efficacy of its investigational therapy for the treatment of moderate-to-severe hidradenitis suppurativa (HS), a chronic skin condition that causes small, but painful lumps under the skin. This case study will highlight IQVIA Biotech’s unique strategies for site selection and centralized recruitment approach to drive enrollment.

  • A biologics company needed a CRO with oncology experience that could support protocol design and accelerate the start-up process to meet a quick first-patient-in (FPI) milestone. In this case study, discover how this partner evaluated the safety and pharmacokinetic (PK) profile of an immunotherapeutic drug in subjects with advanced solid tumors.

  • Learn how IQVIA Biotech helped a biotechnology company reach critical milestones as it prepared to launch an international Phase III clinical trial for its investigational ALK inhibitor in patients with non-small cell lung cancer.

  • Read how this RFP planning guide helps oncology sponsors identify key cost drivers, save time, and make planning easier, while navigating clinical outsourcing, with timeline and financial considerations in mind.

  • In this article, explore how virtual models can improve patient retention in long-term follow-up studies, cutting the time, cost, and burden for patients and investigators.

  • The global pandemic has added complexity to the already nuanced clinical development landscape, making innovation within clinical research critical to advancing human health. There are many factors that play a role in how trial adjustments are implemented. This paper will discuss how clinical trial models are evolving as sponsors rethink the traditional research paradigm and adopt patient-centric clinical technologies and approaches, including telemedicine and remote clinical monitoring.

  • COVID-19 accelerated interest in the use of virtual trials as a way to keep trials running through the pandemic. It was an unexpected shift, but it has helped many sponsors and sites see the value of virtual for clinical research and identify where and when virtual trial elements may bring permanent benefits to clinical research, even after the pandemic is over.

  • This short video explains how and why business process outsourcing (BPO) using IQVIA Technologies for site payments offers excellent ROI for sponsors and peace of mind for sites and investigators.